When States Step Up: California and the Case for State-Led Insulin Manufacturing
Authors: Mariana P. Socal, Vishaal Pegany, Mark Ghaly
Journal: Annals of Internal Medicine (2022)

Ideas and OpinionsDecember 2022When States Step Up: California and the Case for State-Led Insulin ManufacturingMariana P. Socal, MD, PhD, Vishaal Pegany, MPP, MPH, and Mark Ghaly, MD, MPHMariana P. Socal, MD, PhDDepartment of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (M.P.S.), Vishaal Pegany, MPP, MPHCalifornia Health and Human Services Agency, Sacramento, California (V.P., M.G.)., and Mark Ghaly, MD, MPHCalifornia Health and Human Services Agency, Sacramento, California (V.P., M.G.).Author, Article, and Disclosure Informationhttps://doi.org/10.7326/M22-2339 Annals Author Insight Video - Mariana P. Socal, MD, PhD and Mark Ghaly, MD, MPH In this video, Mariana P. Socal, MD, PhD and Mark Ghaly, MD, MPH, offer additional insight into the article, "When States Step Up: California and the Case for State-Led Insulin Manufacturing." (Duration 3:55) SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail The high cost of insulin is a matter of great concern to the people of California and around the nation. Roughly 1 in 4 persons taking insulin have taken less quantity than prescribed in the past year because they were unable to afford it (1). Those who cannot regularly use insulin have worse diabetes control, being at risk for diabetes exacerbations, long-term complications, and death. To remedy the crisis of insulin affordability, the state of California is trying a new approach: state-led insulin manufacturing.Insulin prices in the United States are, on average, 5 to 10 times higher than in ...References1. Herkert D, Vijayakumar P, Luo J, et al. Cost-related insulin underuse among patients with diabetes. JAMA Intern Med. 2019;179:112-4. [PMID: 30508012] doi:10.1001/jamainternmed.2018.5008 CrossrefMedlineGoogle Scholar2. Mulcahy AW, Schwam D, Edenfield N. Comparing insulin prices in the United States to other countries: results from a price index analysis. Accessed at www.rand.org/pubs/research_reports/RRA788-1.html on 31 July 2022. Google Scholar3. Levy J, Chowdhury ZM, Socal MP, et al. Changes associated with the entry of a biosimilar in the insulin glargine market. JAMA Intern Med. 2021;181:1405-7. [PMID: 34180955] doi:10.1001/jamainternmed.2021.2769 CrossrefMedlineGoogle Scholar4. Kang SY, Bai G, DiStefano MJ, et al. Comparative approaches to drug pricing. Annu Rev Public Health. 2020;41:499-512. [PMID: 31874070] doi:10.1146/annurev-publhealth-040119-094305 CrossrefMedlineGoogle Scholar5. State of California. SB-852 health care: prescription drugs. Accessed at https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201920200SB852 on 29 June 2022. Google Scholar6. State of California. Budget change proposal 4140-079-BCP-2022-A1: reducing the cost of insulin: CalRx Biosimilar Insulin Initiative. Accessed at https://esd.dof.ca.gov/Documents/bcp/2223/FY2223_ORG4140_BCP5779.pdf on 31 July 2022. Google Scholar7. U.S. Food and Drug Administration. Purple Book Database of Licensed Biological Products. Accessed at https://purplebooksearch.fda.gov/ on 22 September 2022. Google Scholar8. Drug Channels Institute. Why PBMs and payers are embracing insulin biosimilars with higher prices—and what that means for Humira. Accessed at www.drugchannels.net/2021/11/why-pbms-and-payers-are-embracing.html on 31 July 2022. Google Scholar9. U.S. Food and Drug Administration. Biosimilar development, review, and approval. Accessed at www.fda.gov/drugs/biosimilars/biosimilar-development-review-and-approval#process on 22 September 2022. Google Scholar Author, Article, and Disclosure InformationAffiliations: Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (M.P.S.)California Health and Human Services Agency, Sacramento, California (V.P., M.G.).Disclaimer: The findings and conclusions in this manuscript are those of the authors and do not necessarily represent the views of Arnold Ventures.Acknowledgment: The authors thank Andrew Xuan, MPH, and Kelly Anderson, MPP, PhD, for their assistance with statistical analyses, as well as David Toppelberg, BA, JD (candidate), and Gerard Anderson, PhD, for their critical review of the manuscript.Grant Support: By Arnold Ventures (Dr. Socal).Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M22-2339.Corresponding Author: Mariana P. Socal, MD, PhD, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, 624 North Broadway, Suite HH301, Baltimore, MD 21205; e-mail, [email protected]edu.Author Contributions: Conception and design: M. Ghaly, V. Pegany, M.P. Socal.Analysis and interpretation of the data: M.P. Socal.Drafting of the article: V. Pegany, M.P. Socal.Critical revision of the article for important intellectual content: V. Pegany, M.P. Socal.Final approval of the article: M. Ghaly, V. Pegany, M.P. Socal.Provision of study materials or patients: V. Pegany.Statistical expertise: M.P. Socal.Administrative, technical, or logistic support: V. Pegany.Collection and assembly of data: M.P. Socal.This article was published at Annals.org on 15 November 2022. PreviousarticleNextarticle Advertisement Annals Author Insight Video - Mariana P. Socal, MD, PhD and Mark Ghaly, MD, MPH In this video, Mariana P. Socal, MD, PhD and Mark Ghaly, MD, MPH, offer additional insight into the article, "When States Step Up: California and the Case for State-Led Insulin Manufacturing." (Duration 3:55) FiguresReferencesRelatedDetails Metrics Cited byCompetition And Vulnerabilities In The Global Supply Chain For US Generic Active Pharmaceutical IngredientsAssessing—and Extending—California's Insulin Manufacturing Initiative December 2022Volume 175, Issue 12Page: 1756-1758KeywordsDrug pricesInsulinType 1 diabetesType 2 diabetes ePublished: 15 November 2022 Issue Published: December 2022 Copyright & PermissionsCopyright © 2022 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...